FDA Comment Deadline: Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics To Treat Pain and Addiction

Monday, November 18, 2019 - 5:00pm

The Food and Drug Administration (FDA) seeks public comments to accompany its September 17, 2019 public hearing entitled “Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction.” The hearing relates to the draft guidance on the application of FDA's existing benefit-risk assessment framework to applications for approval of opioid analgesic drugs.

This public hearing is intended to receive stakeholder input on the approval process for new opioids and how FDA might best consider the existing armamentarium of therapies, among other factors, in reviewing applications for new opioids to treat pain. FDA also seeks input on potential new preapproval incentives aimed at fostering the development of new therapeutics to treat pain, as well as new treatments for addiction.

Members of the public may submit comments online at Regulations.gov, or via mail. More information is available at this Federal Register notice.